Plans to reintroduce the troubled LOTUS Edge Aortic Valve System into the European market have stalled, Boston Scientific reported Tuesday.
All LOTUS valves—used across the world in TAVR procedures—were voluntarily recalled in February 2017 by Boston Scientific due to an issue with its locking mechanism. The company announced it expected to reintroduce the product to the market by the end of 2017, but that date has been moved to the first quarter of 2018.
Chairman and CEO Mike Mahoney said in a statement he and his colleagues are disappointed by the delay but need to take time to implement changes to keep LOTUS valves in line with Boston Scientific’s “rigorous internal quality standards.”
The company said it will provide an update in early February on the status of the LOTUS Edge Valve as it continues to focus on manufacturing and regulatory milestones. No new timeline for a relaunch in Europe was provided.